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NCT01488890 · ClinicalTrials.gov registry record · Phase 2

Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine

A Phase 2 study of Dengue and Yellow Fever, sponsored by Sanofi Pasteur, a Sanofi Company.

Completed
Registry status
Phase 2
Development phase
390
Enrollment target
7
Study locations

NCT01488890 is a Phase 2 study of Dengue and Yellow Fever that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 390 participants, below the 3,938-participant average among 9 other Dengue trials with a reported enrollment target (90% lower). The trial reports 7 study locations across 7 states.

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The verdict

NCT01488890, a Phase 2 study of Dengue and Yellow Fever, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.

COMPLETED
Registry status
Phase 2
Development phase
390 participants
Enrollment target
7
Study locations

Study Summary

The aim of this study was to evaluate the administration of CYD dengue vaccine serotypes (1, 2, 3 and 4) following a compressed schedule in 3 different populations. Primary Objectives: * To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 3 in Group 1 (Month \[M\] 13) and Group 2 (M07), irrespective of whether or not Yellow Fever (YF) vaccine has been previously administered. * To describe the persistence of the humoral immune response to each of the 4 parental dengue virus serotypes 6 months after CYD dengue vaccine Dose 3 in Group 1 (M18) and Group 2 (M12), irrespective of whether or not YF vaccine has been previously administered. Secondary Objective: * To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue vaccine Dose 1 and Dose 2 in Groups 1 and 2, irrespective of whether or not YF vaccine has been previously administered. * To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after CYD dengue Dose 1 in the combined YF-participants in Group 1 (N=60) and Group 2 (N=60), and in Group 3 (N=120). * To describe by FV status at baseline the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 days after each injection of CYD dengue vaccine in Groups 1, 2, and 3. * To describe the safety profile after each injection of CYD dengue vaccine and/or YF vaccine.

Conditions Studied

Dengue Yellow Fever Dengue Hemorrhagic Fever Dengue Fever

Interventions

  • BIOLOGICAL Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
  • BIOLOGICAL Yellow Fever

Study Locations (7)

Alabama

  • - Alabaster

California

  • - Sacramento

Florida

  • - Jacksonville

Maryland

  • - Silver Spring

Missouri

  • - Springfield

Nevada

  • - Las Vegas

Utah

  • - West Jordan

Trial Details

FieldValue
Enrollment Target 390 participants
Start Date 2011-12-06
Est. Completion 2013-09-27
Phase Phase 2

Sponsor

Sanofi Pasteur, a Sanofi Company

153 total trials

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What the Registry Record Tells You About NCT01488890

The ClinicalTrials.gov registry entry for NCT01488890 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 390 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,938-participant average among 9 other Dengue trials with a reported enrollment target (90% lower). The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 153 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Dengue appearing as the primary indexed condition, and to 2 interventions - of which Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus is the first listed.

NCT01488890 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Alabama, California, Florida.

Frequently Asked Questions

What is clinical trial NCT01488890 about?

NCT01488890 is a clinical study titled "Immune Response to Different Schedules of a Tetravalent Dengue Vaccine Given With or Without Yellow Fever Vaccine". The aim of this study was to evaluate the administration of CYD dengue vaccine serotypes (1, 2, 3 and 4) following a compressed schedule in 3 different populations. Primary Objectives: * To describe the humoral immune response to each of the 4 parental dengue virus serotypes at baseline and 28 day...

What is the current status of trial NCT01488890?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 390 participants. The study started on 2011-12-06. Estimated completion is 2013-09-27.

What conditions does trial NCT01488890 study?

This clinical trial studies the following conditions: Dengue, Yellow Fever, Dengue Hemorrhagic Fever, Dengue Fever.

What interventions are being tested in trial NCT01488890?

The interventions under investigation include: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus (BIOLOGICAL), Yellow Fever (BIOLOGICAL).

Who is sponsoring clinical trial NCT01488890?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01488890 being conducted?

This trial has 7 study locations across Alabama, California, Florida, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.